CLINIMIX- leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, ar

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), LYSINE (UNII: K3Z4F929H6) (LYSINE - UNII:K3Z4F929H6), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8DUH1N11BX

Boleh didapati daripada:

Baxter Healthcare Corporation

INN (Nama Antarabangsa):

LEUCINE

Komposisi:

LEUCINE 201 mg in 100 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. The use of CLINIMIX is contraindicated in: Risk Summary There are no adequate or well-controlled studies in pregnant women with CLINIMIX. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition sh

Ringkasan produk:

CLINIMIX (amino acids in dextrose) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Minimize exposure of CLINIMIX to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective overwrap has been opened. Do not use if the protective overwrap has been previously opened or damaged. For storage of admixed solutions see Dosage and Administration (2.3, 2.4) .

Status kebenaran:

New Drug Application

Ciri produk

CLINIMIX- LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE,
VALINE,
HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE,
SERINE,
TYROSINE, DEXTROSE INJECTION
CLINIMIX- LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE,
VALINE,
HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE,
SERINE,
TYROSINE, DEXTROSE INJECTION, EMULSION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINIMIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLINIMIX.
CLINIMIX (AMINO ACIDS IN DEXTROSE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
CLINIMIX is indicated as a source of calories and protein for patients
requiring parenteral nutrition when
oral or enteral nutrition is not possible, insufficient, or
contraindicated. CLINIMIX may be used to treat
negative nitrogen balance in patients. (1)
DOSAGE AND ADMINISTRATION
See full prescribing information for information on preparation,
administration, instructions for use, dosing
considerations, including the recommended dosage in adults and
pediatrics, and dosage modifications in
patients with kidney disease. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8)
DOSAGE FORMS AND STRENGTHS
CLINIMIX injection is available in multiple strengths. See full
prescribing information for detailed description
of each formulation. (3, 11)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions include diuresis, extravasation, glycosuria,
hyperglycemia, and hyperosmolar coma. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE
CORPORATION AT 1-
866-888-2472 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
Pediatric Use: increased risk of hypoglycemia/hyperglycemia: monitor
serum glucose concentrations. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2021
FULL PRESCRIBING INFORMATION: